Immune Globulin Side Effects with Vivaglobin® Therapy

Vivaglobin^® is a Sub-Q Ig therapy and not intravenous—meaning that you infuse Vivaglobin^® directly into the tissue just under your skin and not through a vein.

Because of this fact, some of the potential side effects of Vivaglobin® differ from those of IVIg therapy. The most common side effects of Vivaglobin® are local infusion-site reactions. The most common noninjection-site side effects are headaches.

Patients report fewer serious side effects with Vivaglobin^® than with IVIg therapy. The most common side effects from Vivaglobin^® are mild to moderate injection-site reactions.

These might appear as a dime- to half dollar-sized areas of raised skin. When they occur, they are associated with mild to moderate redness, itching, or discomfort. In moderate cases, the affected area can be larger with increased discomfort. These side effects are normal and easy to treat. Injection-site reactions occur less frequently and diminish with continued therapy of 4–6 months.

A mild injection-site reaction is normal after an infusion. Over the course of 24 to 48 hours, these symptoms will decrease. Frequency diminishes after approximately 4–6 months of use.
A moderate injection-site reaction can also be a normal after an infusion. Over the course of 24 to 48 hours, these symptoms will decrease. Frequency diminishes after approximately 4–6 months of use.

These injection-site reactions usually decrease within 24 to 48 hours after your infusion. With continued therapy, the frequency of injection-site reactions also decreases.

Be sure to ask your doctor to review common injection-site reactions with you and discuss how you can prevent, treat, and minimize these symptoms when they occur.

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Important Safety Information

Immune Globulin Subcutaneous (Human), Vivaglobin^®, is a prescription treatment for patients with primary immunodeficiency (PI).

Immune globulin products, such as Vivaglobin^®, should not be taken if you have a history of anaphylactic or severe systemic response to immune globulin (Ig) preparations. If you suspect you are having a severe reaction to Vivaglobin^®, discontinue treatment immediately and inform your doctor.

Vivaglobin^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical trials, the most frequent adverse event was mild or moderate swelling, redness, and itching at the injection site. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash. No serious reactions were observed, and reactions tended to decrease substantially with repeated use.

If you are receiving Ig therapy for the first time, are new to Vivaglobin^®, or have not received Ig therapy within the past eight weeks, your healthcare provider should monitor your initial treatment with Vivaglobin^®, as you could experience reactions including fever, chills, nausea, and vomiting. Rarely, these reactions may lead to shock.

Ig administration may impair the effectiveness of virus vaccines, such as measles, mumps and rubella. Consult your doctor if you plan to receive any vaccine.

In clinical studies, Vivaglobin^® has been shown to be safe and well tolerated in pediatric patients, without pediatric-specific dose requirements. Safety and effectiveness were not studied in subjects under 2 years of age.

Please see full Prescribing Information and Patient Product Information.